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26-03-2019 | Rheumatoid arthritis | News

Regulatory update

EMA warns of increased risk for pulmonary embolism and death with higher dose of tofacitinib


medwireNews: The EMA has issued a safety alert warning that the recommended 5 mg twice daily dose of the Janus kinase inhibitor tofacitinib should not be exceeded when treating rheumatoid arthritis (RA).

This announcement in March 2019 follows a similar caution from the US FDA earlier in the same month, and is based on interim results from an ongoing safety study demonstrating an increased risk for pulmonary embolism and death associated with the 10 mg twice daily dose of tofacitinib, currently approved for the treatment of ulcerative colitis in the European Union.

The EMA says that it “is assessing the early results and will consider if any regulatory action is needed.” Meanwhile, it is recommended that healthcare professionals should adhere to the 5 mg twice daily dose for the treatment of RA and monitor patients for signs and symptoms of pulmonary embolism.

By Claire Barnard

medwireNews is an independent medical news service provided by Springer Healthcare. © 2019 Springer Healthcare part of the Springer Nature group

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